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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 3822
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2020
Event Type  malfunction  
Event Description
It was reported that a balloon leak occurred.A 10/2.50 flextome cutting balloon was selected for use.During the procedure, the balloon would not inflate and no contrast has appeared.When the device was deflated, it was noted that the blood returned to the indeflator.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon wings had been subjected to positive pressure.The device was attached to an encore inflation unit and positive pressure was applied.Liquid was observed to be leaking from a balloon pinhole located approximately 5mm distally of the proximal marker band.An examination of the balloon material and marker bands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.No issues were noted with the hypotube/shaft of the device.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.
 
Event Description
It was reported that a balloon leak occurred.A 10/2.50 flextome cutting balloon was selected for use.During the procedure, the balloon would not inflate and no contrast has appeared.When the device was deflated, it was noted that the blood returned to the indeflator.The procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
FLEXTOME CUTTING BALLOON
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9602161
MDR Text Key178040074
Report Number2134265-2020-00177
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2021
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0022874809
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2020
Initial Date Manufacturer Received 01/06/2020
Initial Date FDA Received01/17/2020
Supplement Dates Manufacturer Received09/29/2020
Supplement Dates FDA Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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